AIT Bioscience
  • - Small Molecule
  • Indianapolis, IN, USA
  • Salary
  • Full Time

Opportunity for a skilled bioanalytical scientist to join an exciting, growing contract research organization!

AIT Bioscience (AITB) is a leading bioanalytical services contract research organization (CRO), serving the pharmaceutical, biotech, and animal health industries. LC-MS/MS and multiple large molecule platforms combine to provide regulatory compliant bioassay support development of new medicines from Discovery to Pre-Clinical and Clinical through Commercialization.

AITB is the first and only CRO in the world to provide solutions for all molecule types (large, small, and peptides/biomarkers) in a purpose-built facility utilizing a fully electronic analytical lab notebook system. With our customized, real-time QC system, quality has literally been built into everything we do and everywhere we do it. Bioanalytical capabilities and expertise support both stand-alone projects and full IND/NDA enabling programs, allowing AITB to support its clients with a hands-on approach, scientific collaboration, high quality, and on-time delivery.

Due to our continued growth, AITB is seeking an experienced Bioanalytical Method Development Scientist/Principal Investigator/Project Manager with expertise in LC-MS/MS bioanalysis for our Indianapolis laboratory. The Principal Investigator is primarily responsible for small molecule and biomarker method development and validation studies.

Summary of Job Responsibilities
• Serves as a Responsible Scientist or Principal Investigator (PI) for non-regulated and GLP-regulated assay development and validation studies.
• Ensures client small molecule, biomarker, LC-MS/MS programs meet AIT Bioscience, sponsor, and regulatory requirements.
• Serves as the scientific point of contact for the sponsor.
• Develops method development and validation experiments for execution
• Independently performs analysis, interpretation and develops conclusions from analytical data. Reviews and approves raw data.
• Reviews data to ensure methods are ready for validation. Approves validation methods and reviews sample analysis methods.
• Depending on workload, continues laboratory work through to sample analysis, as applicable
• Reviews and approves reports for scientific accuracy and completeness.
• Takes accountability and demonstrates responsibility regarding scientific study conduct.
• Actively promotes collaboration within and across groups.
• Provides appropriate coaching and recognition to team members.
• Promotes a positive impression of AIT Bioscience internally and within the industry.
• Plans, prioritizes, and manages workload for large and complex projects.
• Assists in business development activities.

Education / Qualifications
• BSc, MS, PhD or equivalent in Analytical Chemistry, Chemistry, Biochemistry or a closely related field.
• Experience conducting method development, validation and analysis to support toxicokinetic, pharmacokinetic (TK/PK) assays and biomarker assays in a pharmaceutical or contract research organization (CRO) environment under FDA/EMA regulations
• Demonstrated mathematical, reasoning and computer skills to apply principles of logical and scientific thinking and performance to a wide range of bioanalytical projects.
• 5+ years of assay development experience. This means you can take a structure and then develop, optimize and validate an assay from scratch.
• 3+ years as a Principal Investigator (PI) in a GLP compliant lab.
• Knowledge of global regulatory bioanalytical agency guidelines.
• Operate, calibrate and maintain laboratory equipment and analytical instruments
• Experience with Thermo LC-MS/MS platform preferred.
• Experience with Watson® LIMS preferred.
• Excellent communication and interpersonal skills.
• Proven ability to prioritize and manage time.
• Excellent attention to detail.
• Able to utilize word processing, database, spreadsheet, and specialized software.

Due to the unique systems employed by AIT Bioscience, this person must also have a high level of competency in computer systems and be comfortable with the concept and practice of operating in a paperless environment. The department has been an early adopter in the use of electronic laboratory note books for regulated bioanalysis.

This position has been closed and is no longer available.
AIT Bioscience


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